MAUDE Adverse Event Report: INTERVASCULAR INTERGARD WOVEN GRAFT; VASCULAR GRAFT PROSTHESIS

Model Number IGW008-30

Device Problem Manufacturing, Packaging or Shipping Problem (2975)

Patient Problem Aneurysm (1708)

Event Date 02/17/2014

Event Type  malfunction  

Event Description

On (b)(6) 2014, the patient underwent a vascular surgery for annuloaortic ectasia.The involved graft was used for extracorporeal circulation.It was cut in half and anastomosed to subclavian artery and femoral artery.Blood leaking was noted from the entire surface of the graft.No action was required to stop the bleeding.Surgery was prolonged an unknown amount of time.The procedure was continued after bleeding stopped.No patient injury was reported.

Manufacturer Narrative

The device was sent to an outside laboratory for scanning electron microscopy analysis.A review of the device history records, including collagen coating records, indicated that the graft was processed and inspected according to procedures and no anomaly was found.Specifically, the review of the water permeability testing of six products coated on the same day and under the same conditions as the complaint device indicated values will within product specifications.One retention sample coated on the same period and under the same conditions as the complaint device underwent water permeability testing at 1200 mmhg as per iso 7198.The test result indicated a value well within product specifications.The investigation is still ongoing.A follow-up report will be submitted upon completion of the investigation.

• Brand Name: INTERGARD WOVEN GRAFT
• Type of Device: VASCULAR GRAFT PROSTHESIS
• Manufacturer (Section D): INTERVASCULAR; zi athelia 1; la ciotat cedex 1360 5; FR 13605
• Manufacturer Contact: pascal de framond ; zi athelia 1; la ciotat cedex 13605 ; FR 13605
• MDR Report Key: 3806829
• MDR Text Key: 4479474
• Report Number: 1640201-2014-00006
• Device Sequence Number: 1
• Product Code: DSY
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K970843
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/18/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/18/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/01/2018
• Device Model Number: IGW008-30
• Device Catalogue Number: IGW008-30
• Device Lot Number: 13G04
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 02/27/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/18/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/01/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other